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Mycophenolate Mofetil 250 mg Capsule, 100-count — NDC 65050-2073-0 (Billing 65050-2073-00)

by Wuxi Fortune Pharmaceutical Co.,Ltd. · 100 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 100 capsules of Mycophenolate Mofetil 250 mg Capsule from Wuxi Fortune Pharmaceutical Co.,Ltd., marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 65050-2073-00
🏷️ FDA NDC (as labeled) 65050-2073-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Mycophenolate Mofetil (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 26, 2026 — Failed Dissolution Specifications (Mylan Pharmaceuticals Inc) · FDA recall D-0830-2026
Class II · Jul 2, 2026 — Presence of precipitate (MYLAN PHARMACEUTICALS INC) · FDA recall D-0734-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65050-2073-0
Product NDC 65050-2073
11-digit billing NDC 65050207300
RxCUI 199058
UNII 9242ECW6R0
Application # ANDA214079
SPL Set ID ca633c6a-1e58-4faa-8e5d-71f89cefaa01
Established class (EPC) Antimetabolite Immunosuppressant
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-10
Route ORAL
Dosage form CAPSULE
Substance MYCOPHENOLATE MOFETIL
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 199058
Why two NDCs? The FDA registers this code as 65050-2073-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 65050-2073-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It helps keep your body from rejecting a transplanted kidney, heart or liver. You take it together with other immunosuppressant medicines. It works by calming the immune cells that...
  • It's usually taken twice a day, by mouth as a capsule, tablet or liquid, or through an IV in the hospital. Follow your prescriber's directions and your label. Don't switch it with...
  • Diarrhea, nausea, vomiting and stomach pain are common. Call your doctor if you have a fever, chills or other signs of infection, unusual bruising or bleeding, black stools, severe...
  • What side effects are normal, and when should I call?
📖 Read our full Mycophenolate Mofetil guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2914 $29.14 / 100 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65050-2073-00 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE, PLASTIC 2025-11-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mycophenolate Mofetil 250 mg 00054-0163-25 Hikma 100 capsules $0.138 — Discontinued —
Mycophenolate Mofetil 250 mg 00093-7334-01 Teva 100 capsules $0.138 AB Availability likely —
Mycophenolate Mofetil 250 mg 00781-2067-01 Sandoz 100 capsules $0.138 AB Availability likely —
mycophenolate mofetil 250 mg 00904-7466-61 Major 100 capsules $0.138 AB Availability likely —
mycophenolate mofetil 250 mg 16729-0094-01 Accord 100 capsules $0.138 AB Availability likely —
Mycophenolate mofetil 250 mg 23155-0830-01 Heritage 100 capsules $0.138 AB Availability likely —
Mycophenolate Mofetil 250 mg 31722-0878-01 Camber 100 capsules $0.138 AB Availability likely —
mycophenolate mofetil 250 mg 50268-0557-15 AvPAK 50 capsules $0.138 AB Availability likely —
Mycophenolate mofetil 250 mg 59651-0624-01 Aurobindo 100 capsules $0.138 AB Availability likely —
mycophenolate mofetil 250 mg 60687-0885-01 American 100 capsules $0.138 AB Availability likely —
Mycophenolate mofetil 250 mg 64380-0726-06 Strides 100 capsules $0.138 AB Availability likely —
mycophenolate mofetil 250 mg 67877-0266-01 Ascend 100 capsules $0.138 AB Availability likely —
Mycophenolate Mofetil 250 mg 72888-0192-01 Advagen 100 capsules $0.138 AB Availability likely —
Mycophenolate Mofetil 250 mg 60687-0494-01 American 100 capsules $0.139 — Discontinued —
CellCept 250 mg 00004-0259-01 Genentech, 100 capsules $8.649 AB Availability likely —
Mycophenolate mofetil 250 mg 42543-0988-07 Strides 500 capsules — AB FDA listed —
Mycophenolate Mofetil 250 mgthis 65050-2073-00 Wuxi 100 capsules — AB FDA listed —
Mycophenolate Mofetil 250 mg 68254-5000-01 CONCORD 100 capsules — AB FDA listed —
Mycophenolate mofetil 250 mg 70518-3799-00 REMEDYREPACK 100 capsules — AB FDA listed —
Mycophenolate Mofetil 250 mg 70518-4036-00 REMEDYREPACK 100 capsules — AB FDA listed —
Mycophenolate mofetil 250 mg 73190-0009-01 AvKARE 100 capsules — AB FDA listed —
mycophenolate mofetil 250 mg 55154-0161-00 Cardinal 10 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerWuxi Fortune Pharmaceutical Co.,Ltd.
Application holderWUXI FORTUNE PHARMACEUTICAL CO LTD
FDA applicationANDA214079 (ANDA)
Labeler code65050
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 181 words ▾

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1)].

Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2)]. Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes [see Warnings and Precautions (5.3)]. WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning.

Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1)].

Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2)]. Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes [see Warnings and Precautions (5.3)].

🎯 Indications and Usage 80 words ▾

1 INDICATIONS AND USAGE Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1)] , heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)] , in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

(1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION ADULTS DOSING Kidney Transplant 1 g twice daily, orally (2.2) Heart Transplant 1.5 g twice daily, orally (2.3) Liver Transplant 1.5 g twice daily, orally (2.4) PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily (2.2) Reduce or interrupt dosing in the event of neutropenia. (2.5) See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia (2.5).

2.1Important Administration Instruction Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy. Mycophenolate Mofetil Capsules Mycophenolate mofetil capsules should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of mycophenolate mofetil capsules and mycophenolic acid delayed-release tablets are not equivalent.

Mycophenolate mofetil capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules. If such contact occurs, they must wash the area of contact thoroughly with soap and water.

In case of ocular contact, rinse eyes with plain water. The initial oral dose of mycophenolate mofetil should be given as soon as possible following kidney, heart or liver transplant. It is recommended that mycophenolate mofetil be administered on an empty stomach.

In stable transplant patients, however, mycophenolate mofetil may be administered with food if necessary [see Clinical Pharmacology (12.3)] . Patients should be instructed to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case, they should continue to take mycophenolate mofetil at the usual times.

2.2Dosage Recommendations for Kidney Transplant Patients Adults The recommended dose for adult kidney transplant patients is 1 g orally, twice daily (daily dose of 2 g). Pediatrics (3 months and older) Pediatric dosing is based on body surface area (BSA). Pediatric patients with BSA 1.25 m 2 may be dosed with capsules as follows: Table 1.

Pediatric Kidney Transplant: Dosage Using Capsules Body Surface Area Dosing 1.25m 2 to <1.5m 2 Mycophenolate mofetil capsules 750 mg twice daily (1.5 g daily dose) ≥1.5 m 2 Mycophenolate mofetil capsules 1 g twice daily (2 g daily dose

2.3Dosage Recommendations for Heart Transplant Patients Adults The recommended dosage of mycophenolate mofetil for adult heart transplant patients is 1.5 g orally administered twice daily (total daily dose of 3 g). Pediatrics (3 months and older) Pediatric patients with BSA 1.25 m 2 may be started on therapy with capsules as follows: Table 2. Pediatric Heart Transplant: Pediatric Starting Dosage Using Capsules Body Surface Area Starting Dosage* 1.25m 2 to <1.5m 2 Mycophenolate mofetil capsules 750 mg twice daily (1.5 g total daily dose) ≥1.5 m 2 Mycophenolate mofetil capsules 1 g twice daily (2 g total daily dose) * Maximum maintenance dose: 3 g total daily.

2.4Dosage Recommendations for Liver Transplant Patients Adults The recommended dosage of mycophenolate mofetil for adult liver transplant patients is 1.5 g administered orally twice daily (total daily dose of 3 g). Pediatrics (3 months and older) Pediatric patients with BSA 1.25 m 2 may be started on therapy with capsules as follows: Table 3. Pediatric Liver Transplant: Pediatric Starting Dosage Using Capsules Body Surface Area Starting Dosage* 1.25m 2 to <1.5m 2 Mycophenolate mofetil capsules 750 mg twice daily (1.5 g total daily dose) ≥1.5 m 2 Mycophenolate mofetil capsules 1 g twice daily (2 g total daily dose) * Maximum maintenance dose: 3 g total daily.

2.5Dosage Modifications: Patients with Renal Impairment, Neutropenia Renal Impairment No dose adjustments are needed in kidney transplant patients with delayed gra… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Mycophenolate Mofetil Capsules USP are available in the following dosage form and strength: Capsules 250 mg mycophenolate mofetil, bBlue-orange, opaque, two-piece, hard gelatin capsules, printed in black with “Wuxifortune” on the blue cap and “F” on the orange body. Capsules: 250 mg

⛔ Contraindications 48 words ▾

4 CONTRAINDICATIONS Mycophenolate mofetil is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product [see Warnings and Precautions (5.8)]. Hypersensitivity to mycophenolate mofetil, MPA acid or any component of the drug product (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Blood Dyscrasias (Neutropenia, Red Blood Cell Aplasia): Monitor with blood tests; consider treatment interruption or dose reduction. (5.4) Gastrointestinal Complications: Monitor for complications such as bleeding, ulceration and perforations, particularly in patients with underlying gastrointestinal disorders. (5.5) Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency: Avoid use of mycophenolate mofetil.

(5.6) Acute Inflammatory Syndrome Associated with Mycophenolate Products: Monitor for this paradoxical inflammatory reaction. (5.7) Hypersensitivity Reactions: Discontinue Mycophenolate mofetil; treat and monitor until signs and symptoms resolve. (5.8) Immunizations: Avoid live attenuated vaccines.

(5.9) Blood Donation: Avoid during therapy and for 6 weeks thereafter. (5.12) Semen Donation: Avoid during therapy and for 90 days thereafter. (5.13) Potential Impairment on Driving and Use of Machinery: Mycophenolate mofetil may affect ability to drive or operate machinery.

(5.15)

5.1Embryofetal Toxicity Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system. Females of reproductive potential must be made aware of these risks and must be counseled regarding pregnancy prevention and planning. Avoid use of MMF during pregnancy if safer treatment options are available [see Use in Specific Populations (8.1, 8.3)] .

5.2Lymphoma and Other Malignancies Patients receiving immunosuppressant, including mycophenolate mofetil, are at increased risk of developing lymphomas and other malignancies, particularly of the skin [see Adverse Reactions (6.1)] . The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. For patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor.

Post-transplant lymphoproliferative disorder (PTLD) developed in 0.4% to 1% of patients receiving mycophenolate mofetil (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of kidney, heart, and liver transplant patients [see Adverse Reactions (6.1)] . The majority of PTLD cases appear to be related to Epstein Barr Virus (EBV) infection. The risk of PTLD appears greatest in those individuals who are EBV seronegative, a population which includes many young children.

In pediatric patients, no other malignancies besides PTLD were observed in clinical trials [see Adverse Reactions (6.1)].

5.3Serious Infections Patients receiving immunosuppressants, including mycophenolate mofetil, are at increased risk of developing bacterial, fungal, protozoal and new or reactivated viral infections, including opportunistic infections. The risk increases with the total immunosuppressive load. These infections may lead to serious outcomes, including hospitalizations and death [see Adverse Reactions (6.1), (6.2)].

Serious viral infections reported include: Polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection JC virus-associated progressive multifocal leukoencephalopathy (PML), and Cytomegalovirus (CMV) infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease. Viral reactivation in patients infected with Hepatitis B and C COVID-19 Consider reducing immunosuppression in patients who develop new infections or reactivate viral infections, weighing the risk that reduced immunosuppression represents to the functioning allograft.

PVAN, especially due to BK virus infection, is associated with serious outcomes, including deteriorating renal function and renal graft l… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Embryofetal Toxicity [see Warnings and Precautions (5.1)] Lymphomas and Other Malignancies [see Warnings and Precautions 5.2)] Serious Infections [see Warnings and Precautions (5.3)] Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4)] Gastrointestinal Complications [see Warnings and Precautions (5.5)] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.7)] Hypersensitivity Reactions [see Warnings and Precautions (5.8)] The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Emprise Pharma, LLC at the toll free number 610-357-4415 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. An estimated total of 1557 patients received mycophenolate mofetil during pivotal clinical trials in the prevention of acute organ rejection. Of these, 991 were included in the three renal studies, 277 were included in one hepatic study, and 289 were included in one cardiac study.

Patients in all study arms also received cyclosporine and corticosteroids. The data described below primarily derive from five randomized, active-controlled double-blind 12-month trials of mycophenolate mofetil in de novokidney (3) heart (1) and liver (1) transplant patients [see Clinical Studies (14.1, 14.2 and 14.3)]. Mycophenolate mofetil Oral The incidence of adverse reactions for mycophenolate mofetil was determined in five randomized, comparative, double-blind trials in the prevention of rejection in kidney, heart and liver transplant patients (two active-and one placebo-controlled trials, one active-controlled trial, and one active-controlled trial, respectively) [see Clinical Studies (14.1, 14.2 and 14.3)].

The three de novokidney studies with 12-month duration compared two dose levels of oral mycophenolate mofetil (1 g twice daily and 1.5 g twice daily) with azathioprine (2 studies) or placebo (1 study) when administered in combination with cyclosporine (Sandimmune®) and corticosteroids to prevent acute rejection episodes. One study also included anti-thymocyte globulin (ATGAM®) induction therapy. In the de novoheart transplantation study with 12-month duration, patients received mycophenolate mofetil 1.5 g twice daily (n=289) or azathioprine 1.5 to 3 mg/kg/day (n=289), in combination with cyclosporine (Sandimmune® or Neoral®) and corticosteroids as maintenance immunosuppressive therapy.

In the de novoliver transplantation study with 12-month duration, patients received mycophenolate mofetil 1 g twice daily intravenously for up to 14 days followed by mycophenolate mofetil 1.5 g twice daily orally or azathioprine 1 to 2 mg/kg/day intravenously followed by azathioprine 1 to 2 mg/kg/day orally, in combination with cyclosporine (Neoral®) and corticosteroids as maintenance immunosuppressive therapy. The total number of patients enrolled was 565. Approximately 53% of the kidney transplant patients, 65% of the heart transplant patients, and 48% of the liver transplant patients were treated for more than 1 year.

Adverse reactions reported in ≥ 20% of patients in the mycophenolate mofetil treatment groups are presented below. The safety data of three kidney transplantation studies are pooled together. Table 5: Adverse Reactions in Controlled Studies of De Novo Kidney, Heart or Liver Transplantation Reported in ≥20% of Patients in the Mycophenolate Mofetil Group Adv… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. (7.1) Mycophenolate mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended.

(7.2) See FPI for other important drug interactions. (7)

7.1Effect of Other Drugs on Mycophenolate Mofetil Table 7 Drug Interactions with Mycophenolate Mofetil that Affect Mycophenolic Acid (MPA) Exposure Antacids with Magnesium or Aluminum Hydroxide Clinical Impact Concomitant use with an antacid containing magnesium or aluminum hydroxide decreases MPA systemic exposure [see Clinical Pharmacology (12.3)], which may reduce mycophenolate mofetil efficacy. Prevention or Management Administer magnesium or aluminum hydroxide containing antacids at least 2h after mycophenolate mofetil administration.

Proton Pump Inhibitors (PPIs) Clinical Impact Concomitant use with PPIs decreases MPA systemic exposure [see Clinical Pharmacology (12.3)], which may reduce mycophenolate mofetil efficacy. Prevention or Management Monitor patients for alterations in efficacy when PPIs are co-administered with mycophenolate mofetil. Examples Lansoprazole, pantoprazole Drugs that Interfere with Enterohepatic Recirculation Clinical Impact Concomitant use with drugs that directly interfere with enterohepatic recirculation, or indirectly interfere with enterohepatic recirculation by altering the gastrointestinal flora, can decrease MPA systemic exposure [see Clinical Pharmacology (12.3)], which may reduce mycophenolate mofetil efficacy.

Prevention or Management Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered with mycophenolate mofetil. Examples Cyclosporine A, trimethoprim/ sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin as well as aminoglycoside, cephalosporin, fluoroquinolone and penicillin classes of antimicrobials Drugs Modulating Glucuronidation Clinical Impact Concomitant use with drugs inducing glucuronidation decreases MPA systemic exposure, potentially reducing mycophenolate mofetil efficacy, while use with drugs inhibiting glucuronidation increases MPA systemic exposure [see Clinical Pharmacology (12.3)], which may increase the risk of mycophenolate mofetil related adverse reactions.

Prevention or Management Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered with mycophenolate mofetil. Examples Telmisartan (induces glucuronidation); isavuconazole (inhibits glucuronidation). Calcium Free Phosphate Binders Clinical Impact Concomitant use with calcium free phosphate binders decrease MPA systemic exposure [see Clinical Pharmacology (12.3)], which may reduce mycophenolate mofetil efficacy.

Prevention or Management Administer calcium free phosphate binders at least 2 hours after mycophenolate mofetil. Examples Sevelamer

7.2Effect of Mycophenolate Mofetil on Other Drugs Table 8 Drug Interactions with Mycophenolate Mofetil that Affect Other Drug Drugs that Undergo Renal Tubular Secretion Clinical Impact When concomitantly used with mycophenolate mofetil, its metabolite MPAG, may compete with drugs eliminated by renal tubular secretion which may increase plasma concentrations and/or adverse reactions associated with these drugs. Prevention or Management Monitor for drug-related adverse reactions in patients with renal impairment. Examples Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir Combination Oral Contraceptives Clinical Impact Concomitant use with mycophenolate mofetil decreased the systemic exposure to levonorgestrel, but did not affect the systemic exposure to ethinylestradiol [see Clinical Pharmacology (12.3)], which m… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Male Patients: Sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment (8.3)

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191. Risk Summary Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see Human Data] .

Oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.02 to 0.1 times the recommended clinical doses in kidney and heart transplant patients) [see Animal Data]. Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman.

The estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in MMF exposed pregnancies, based on published data from pregnancy registries.

Malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. Based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following MMF exposure. Animal Data In animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity.

Oral administration of MMF to pregnant rats from Gestational Day 7 to Day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.03 and 0.02 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA. Oral administration of MMF to pregnant rabbits from Gestational Day 7 to Day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.1 and 0.06 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA.

8.2Lactation Risk Summary There are no data on the presence of mycophenolate in human milk, or the effects on milk production. There are limited data in the National Transplantation Pregnancy Registry on the effects of mycophenolate on a breastfed child [see Data]. Studies in rats treated with MMF have shown mycophenolic acid (MPA) to be present in milk.

Because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil or from the underlying maternal condition. Data Limited information is available from the National Transplantation Pregnancy Registry.

Of seven infants reported by the Nati… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 189 words ▾

10 OVERDOSAGE Possible signs and symptoms of acute overdose include hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, vomiting, and dyspepsia. The experience with overdose of mycophenolate mofetil in humans is limited. The reported effects associated with overdose fall within the known safety profile of the drug.

The highest dose administered to kidney transplant patients in clinical trials has been 4 g/day. In limited experience with heart and liver transplant patients in clinical trials, the highest doses used were 4 g/day or 5 g/day. At doses of 4 g/day or 5 g/day, there appears to be a higher rate, compared to the use of 3 g/day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, particularly neutropenia [see Warnings and Precautions (5.4)] .

Treatment and Management MPA and the phenolic glucuronide metabolite of MPA (MPAG) are usually not removed by hemodialysis. However, at high MPAG plasma concentrations (>100 μg/mL), small amounts of MPAG are removed. By increasing excretion of the drug, MPA can be removed by bile acid sequestrants, such as cholestyramine [see Clinical Pharmacology (12.3)] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of guanosine nucleotide synthesis and blocks DNA synthesis. The mechanism of action of MPA is multifaceted and includes effects on cellular checkpoints responsible for metabolic programming of lymphocytes.

MPA shifts transcriptional activities in lymphocytes from a proliferative state to catabolic processes. In vitro studies suggest that MPA modulates transcriptional activities in human CD4+ T-lymphocytes by suppressing the Akt/mTOR and STAT5 pathways that are relevant to metabolism and survival, leading to an anergic state of T-cells whereby the cells become less responsive to antigenic stimulation. Additionally, MPA enhanced the expression of negative co-stimulators such as CD70, PD-1, CTLA-4, and transcription factor FoxP3 as well as decreased the expression of positive co-stimulators CD27 and CD28.

MPA decreases proliferative responses of T- and B-lymphocytes to both mitogenic and allo-antigenic stimulation, antibody responses, as well as the production of cytokines from lymphocytes and monocytes such as GM-CSF, IFN-ɣ, IL-17, and TNF-α. Additionally, MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. Overall, the effect of MPA is cytostatic and reversible.

12.2Pharmacodynamics There is a lack of information regarding the pharmacodynamic effects of MMF.

12.3Pharmacokinetics Absorption Following oral and intravenous administration, MMF undergoes complete conversion to MPA, the active metabolite. In 12 healthy volunteers, the mean absolute bioavailability of oral MMF relative to intravenous MMF was 94%. Two 500 mg CELLCEPT tablets have been shown to be bioequivalent to four 250 mg mycophenolate mofetil capsules.

Five mL of the 200 mg/mL constituted CELLCEPT oral suspension have been shown to be bioequivalent to four 250 mg capsules. The mean (±SD) pharmacokinetic parameters estimates for MPA following the administration of MMF given as single doses to healthy volunteers, and multiple doses to kidney, heart, and liver transplant patients, are shown in Table 10. The area under the plasma-concentration time curve (AUC) for MPA appears to increase in a dose-proportional fashion in kidney transplant patients receiving multiple oral doses of MMF up to a daily dose of 3 g (1.5g twice daily) (see Table 10).

Table 10. Pharmacokinetic Parameters for MPA [mean (± SD)] Following Administration of MMF to Healthy Volunteers (Single Dose), and Kidney, Heart, and Liver Transplant Patients (Multiple Doses) Healthy Volunteers Dose/Route T max (h) C max (mcg/mL) Total AUC (mcgh/mL) Single dose 1 g/oral 0.80 (±0.36) (n=129) 24.5 (±9.5) (n=129) 63.9 (±16.2) (n=117) Kidney Transplant Patients (twice daily dosing) Time After Transplantation Dose/Route T max (h) C max (mcg/mL) Interdosing Interval AUC(0-12h) (mcgh/mL) 5 days 1 g/iv 1.58 (±0.46) (n=31) 12.0 (±3.82) (n=31) 40.8 (±11.4) (n=31) 6 days 1 g/oral 1.33 (±1.05) (n=31) 10.7 (±4.83) (n=31) 32.9 (±15.0) (n=31) Early (Less than 40 days) 1 g/oral 1.31 (±0.76) (n=25) 8.16 (±4.50) (n=25) 27.3 (±10.9) (n=25) Early (Less than 40 days) 1.5 g/oral 1.21 (±0.81) (n=27) 13.5 (±8.18) (n=27) 38.4 (±15.4) (n=27) Late (Greater than 3 months) 1.5 g/oral 0.90 (±0.24) (n=23) 24.1 (±12.1) (n=23) 65.3 (±35.4) (n=23) Heart transplant Patients (twice daily dosing) Time After Transplantation Dose/Route T max (h) C max (mcg/mL) Interdosing Interval AUC(0-12h) (mcgh/mL) Early (Day before discharge) 1.5 g/oral 1.8 (±1.3) (n=11) 11.5 (±6.8) (n=11) 43.3 (±20.8) (n=9) Late (Greater than 6 mont… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1Handling and Disposal Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . Mycophenolate mofetil capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in mycophenolate mofetil capsules [see Dosage and Administration (2)] .

Follow applicable special handling and disposal procedures 1 .

16.2Mycophenolate mofetil capsules 250 mg Capsules Blue-orange, opaque, two-piece, hard gelatin capsules, printed in black with “Wuxifortune” on the blue cap and “F” on the orange body. Sizes Bottle of 100 NDC 65050-2073-0 Storage Store at 25°C (77°F); excursions permitted to 15 to 35°C (59 to 86°F) [See USP Controlled Room Temperature].

16.1Handling and Disposal Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . Mycophenolate mofetil capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in mycophenolate mofetil capsules [see Dosage and Administration (2)] .

Follow applicable special handling and disposal procedures 1 .

16.2Mycophenolate mofetil capsules 250 mg Capsules Blue-orange, opaque, two-piece, hard gelatin capsules, printed in black with “Wuxifortune” on the blue cap and “F” on the orange body. Sizes Bottle of 100 NDC 65050-2073-0 Storage Store at 25°C (77°F); excursions permitted to 15 to 35°C (59 to 86°F) [See USP Controlled Room Temperature].

📋 Description 209 words ▾

11 DESCRIPTION Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate.

It has an empirical formula of C 23 H 31 NO 7 , a molecular weight of 433.50, and the following structural formula: MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 μg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol.

The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W).

The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF. Inactive ingredients in mycophenolate mofetil 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch.

The capsule shells contain FD&C red #3, FD&C blue #1, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. structural formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use)

17.1Embryofetal Toxicity Pregnancy loss and malformations Inform females of reproductive potential and pregnant women that use of mycophenolate mofetil during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Advise that they must use an acceptable form of contraception [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)]. Encourage pregnant women to enroll in the Pregnancy Exposure Registry.

This registry monitors pregnancy outcomes in women exposed to mycophenolate [see Use in Specific Populations (8.1)]. Contraception Discuss pregnancy testing, pregnancy prevention and planning with females of reproductive potential [see Use in Specific Populations (8.3)]. Females of reproductive potential must use an acceptable form of birth control during the entire mycophenolate mofetil therapy and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence .

Mycophenolate mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended [see Use in Specific Populations (8.3)]. For patients who are considering pregnancy, discuss appropriate alternative immunosuppressants with less potential for embryofetal toxicity.

Risks and benefits of mycophenolate mofetil should be discussed with the patient. Advise sexually active male patients and/or their partners to use effective contraception during the treatment of the male patient and for at least 90 days after cessation of treatment. This recommendation is based on findings of animal studies [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

17.2Development of Lymphoma and Other Malignancies Inform patients that they are at increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.2)] . Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use of broad-spectrum sunscreen with high protection factor.

17.3Increased Risk of Serious Infections Inform patients that they are at increased risk of developing a variety of infections due to immunosuppression. Instruct them to contact their physician if they develop any of the signs and symptoms of infection explained in the Medication Guide.

17.4Blood Dyscrasias Inform patients that they are at increased risk for developing blood adverse effects such as anemia or low white blood cells. Advise patients to immediately contact their healthcare provider if they experience any evidence of infection, unexpected bruising, or bleeding, or any other manifestation of bone marrow suppression [see Warnings and Precautions (5.4)] .

17.5Gastrointestinal Tract Complications Inform patients that mycophenolate mofetil can cause gastrointestinal tract complications including bleeding, intestinal perforations, and gastric or duodenal ulcers. Advise the patient to contact their healthcare provider if they have symptoms of gastrointestinal bleeding, or sudden onset or persistent abdominal pain [see Warnings and Precautions (5.5)] .

17.6Acute Inflammatory Syndrome Inform patients that acute inflammatory reactions have been reported in some patients who received mycophenolate mofetil. Some reactions were severe, requiring hospitalization. Advise patients to contact their physician if they develop fever, joint stiffness, joint pain or muscle pains [see Warnings and Precautions (5.7)]

17.7Hypersensitivity Reactions Inform patients of the potential risk of hypersensitivity reactions. Advise patients to stop taking mycophenolate mofetil and seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur (such as swelling of face, lips, tongue, or throat; difficulty… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Mycophenolate mofetil capsules, USP (mye'' koe fen' oh late moe' fe til) Read the Medication Guide that comes with mycophenolate mofetil before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about mycophenolate mofetil? Mycophenolate mofetil can cause serious side effects, including: Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects.Females who take mycophenolate mofetil during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects. If you are a female who can become pregnant, your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking mycophenolate mofetil.

You should have 1 pregnancy test immediately before starting mycophenolate mofetil and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests.

You must use acceptable birth control during your entire mycophenolate mofetil treatment and for 6 weeks after stopping mycophenolate mofetil, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolate mofetil decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take mycophenolate mofetil, and you could become pregnant.

If you take birth control pills while using mycophenolate mofetil you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking mycophenolate mofetil. If you are a sexually active male whose female partner can become pregnant while you are taking mycophenolate mofetil, use effective contraception during treatment and for at least 90 days after stopping mycophenolate mofetil.

If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you. If you become pregnant while taking mycophenolate mofetil, do not stop taking mycophenolate mofetil.

Call your doctor right away.You and your doctor may decide that other medicines to prevent rejection may be right for you. You and your doctor should report your pregnancy to the Mycophenolate Pregnancy Registry either: By phone at 1-800-617-8191 or By visiting the REMS website at: www.mycophenolateREMS.com The purpose of this registry is to gather information about the health of you and your baby Increased risk of getting certain cancers.People who take mycophenolate mofetil have a higher risk of getting lymphoma, and other cancers, especially skin cancer.

Tell your doctor if you have: unexplained fever, prolonged tiredness, weight loss or lymph node swelling a change in the size and color of a mole a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other a new skin lesion or bump any other changes to your health Increased risk of getting serious infections.Mycophenolate mofetil weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil and can lead to hospitalizations and death.

These serious infections can include: Viral infections.Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with mycophenolate mofetil include: Shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections.

BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail. Hepatitis B and C viruses… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Kidney Transplantation Adults The three de novokidney transplantation studies compared two dose levels of oral mycophenolate mofetil (1 g twice daily and 1.5 g twice daily) with azathioprine (2 studies) or placebo (1 study) to prevent acute rejection episodes. One of the two studies with azathioprine (AZA) control arm also included anti-thymocyte globulin (ATGAM ® ) induction therapy. The geographic location of the investigational sites of these studies are included in Table 13.

In all three de novokidney transplantation studies, the primary efficacy endpoint was the proportion of patients in each treatment group who experienced treatment failure within the first 6 months after transplantation. Treatment failure was defined as biopsy-proven acute rejection on treatment or the occurrence of death, graft loss or early termination from the study for any reason without prior biopsy-proven rejection. Mycophenolate mofetil, in combination with corticosteroids and cyclosporine, reduced (statistically significant at 0.05 level) the incidence of treatment failure within the first 6 months following transplantation ( Table 13).Patients who prematurely discontinued treatment were followed for the occurrence of death or graft loss, and the cumulative incidence of graft loss and patient death combined are summarized in Table 14.

Patients who prematurely discontinued treatment were not followed for the occurrence of acute rejection after termination. Table 13. Treatment Failure in De Novo Kidney Transplantation Studies USA Study (N=499 patients) Mycophenolate mofetil 2g/day (n=167 patients) Mycophenolate mofetil 3 g/day (n=166 patients) AZA 1 to 2 mg/kg/day (n=166 patients) All 3 groups received anti-thymocyte globulin induction, cyclosporine and corticosteroids All treatment failures 31.1% 31.3% 47.6% Early termination without prior acute rejection 9.6% 12.7% 6.0% Biopsy-proven rejection episode on treatment 19.8% 17.5% 38.0% Europe/Canada/ Australia Study (N=503 patients) Mycophenolate mofetil 2 g/day (n=173 patients) Mycophenolate mofetil 3 g/day (n=164 patients) AZA 100 to 150 mg/day (n=166 patients) No induction treatment administered; all 3 groups received cyclosporine and corticosteroids.

All treatment failures 38.2% 34.8% 50.0% Early termination without prior acute rejection 13.9% 15.2% 10.2% Biopsy-proven rejection episode on treatment 19.7% 15.9% 35.5% Europe Study (N=491 patients) Mycophenolate mofetil 2 g/day (n=165 patients) Mycophenolate mofetil 3 g/day (n=160 patients) Placebo (n=166 patients) No induction treatment administered; all 3 groups received cyclosporine and corticosteroids. All treatment failures 30.3% 38.8% 56.0% Early termination without prior acute rejection 11.5% 22.5% 7.2% Biopsy-proven rejection episode on treatment 17.0% 13.8% 46.4% *Does not include death and graft loss as reason for early termination.

No advantage of mycophenolate mofetil at 12 months with respect to graft loss or patient death (combined) was established ( Table 14). Numerically, patients receiving mycophenolate mofetil 2 g/day and 3 g/day experienced a better outcome than controls in all three studies; patients receiving mycophenolate mofetil 2 g/day experienced a better outcome than mycophenolate mofetil 3 g/day in two of the three studies. Patients in all treatment groups who terminated treatment early were found to have a poor outcome with respect to graft loss or patient death at 1 year.

Table 14. De Novo Kidney Transplantation Studies Cumulative Incidence of Combined Graft Loss or Patient Death at 12 Months Study Mycophenolate mofetil 2 g/day Mycophenolate mofetil 3 g/day Control (AZA or Placebo) USA 8.5% 11.5% 12.2% Europe/Canada/Australia 11.7% 11.0% 13.6% Europe 8.5% 10.0% 11.5% Pediatrics-De Novo Kidney transplantation PK Study with Long Term Follow-Up One open-label, safety and pharmacokinetic study of CELLCEPT oral suspension 600 mg/m 2 twice daily (up to 1 g twice daily) in combination with cyclosporin… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~3 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week oral carcinogenicity study in mice, MMF in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was 0.4 times the recommended clinical dose (2 g/day) in renal transplant patients and 0.3 times the recommended clinical dose (3 g/day) in cardiac transplant patients when corrected for differences in body surface area (BSA). In a 104-week oral carcinogenicity study in rats, MMF in daily doses up to 15 mg/kg was not tumorigenic.

The highest dose was 0.07 times the recommended clinical dose in kidney transplant patients and 0.05 times the recommended clinical dose in heart transplant patients when corrected for BSA. While these animal doses were lower than those given to patients, they were maximal in those species and were considered adequate to evaluate the potential for human risk [see Warnings and Precautions (5.2)]. The genotoxic potential of MMF was determined in five assays.

MMF was genotoxic in the mouse lymphoma/thymidine kinase assay and the in vivo mouse micronucleus assay. MMF was not genotoxic in the bacterial mutation assay, the yeast mitotic gene conversion assay or the Chinese hamster ovary cell chromosomal aberration assay. MMF had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.

This dose represents 0.1 times the recommended clinical dose in renal transplant patients and 0.06 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (principally of the head and eyes) in the first generation offspring in the absence of maternal toxicity. This dose was 0.02 times the recommended clinical dose in renal transplant patients and 0.01 times the recommended clinical dose in cardiac transplant patients when corrected for BSA.

No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week oral carcinogenicity study in mice, MMF in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was 0.4 times the recommended clinical dose (2 g/day) in renal transplant patients and 0.3 times the recommended clinical dose (3 g/day) in cardiac transplant patients when corrected for differences in body surface area (BSA). In a 104-week oral carcinogenicity study in rats, MMF in daily doses up to 15 mg/kg was not tumorigenic.

The highest dose was 0.07 times the recommended clinical dose in kidney transplant patients and 0.05 times the recommended clinical dose in heart transplant patients when corrected for BSA. While these animal doses were lower than those given to patients, they were maximal in those species and were considered adequate to evaluate the potential for human risk [see Warnings and Precautions (5.2)]. The genotoxic potential of MMF was determined in five assays.

MMF was genotoxic in the mouse lymphoma/thymidine kinase assay and the in vivo mouse micronucleus assay. MMF was not genotoxic in the bacterial mutation assay, the yeast mitotic gene conversion assay or the Chinese hamster ovary cell chromosomal aberration assay. MMF had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.

This dose represents 0.1 times the recommended clinical dose in renal transplant patients and 0.06 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (principally of the head and eyes) in the first generation offspring in the absence of maternal toxicity. This dose was 0.02 times the recommended clinical dose in renal transplant patients and 0.01 times the recommended clinical dose in cardiac transplant patients when corrected for BSA.

No effects on fertility or repro… [Excerpted — this section continues on DailyMed.]

📚 References 8 words ▾

15 REFERENCES 1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Recent Major Changes 5 words ▾

Warnings and Precautions (5.8） 05/2025

📄 Package Label / Principal Display Panel 33 words ▾

PRINCIPAL DISPLAY PANEL-250mg Capsule Bottle NDC 65050-207-30 Mycophenolate Mofetil Capsules USP 250mg Each capsule contains 250mg mycophenolate mofetil Rx only Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. 100 capsules JPG

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Mycophenolate Mofetil — the program that covers self-administered drugs. 14 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Mycophenolate Mofetil. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$15.33M
Claims incl. refills
138.6K
Beneficiaries
87.7K
Spend / beneficiary
$174.76
Spend / claim
$110.57
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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← 65050-0527-02 · Wuxi 65050-2101-00 · Wuxi →
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